This invention relates to a pharmaceutical composition in a package in which the active principle is presented in a gel-form excipient.
For several centuries, medicaments have been orally administered as syrups from bottles or in the form of tablets or capsules.
Such presentations are easy to absorb and enable the active substances to be preserved. However, syrups are attended by certain disadvantages, including for example the following:
the high sugar content can be troublesome, for example in diabetics, PA1 the therapeutic dose is not directly accessible, necessitating the use of a measure, for example a spoon, so that the dose administered is not exact, PA1 the method of formulation does not lend itself to the administration of a therapeutic dose in babies and nursing infants who may refuse to take the spoon or may upset the syrup, and PA1 children can take the entire contents of the bottle all at once with the attendant risk of intoxication.
In addition, tablets and capsules are unsuitable for certain patients, for example young children or geriatrics having problems with swallowing.
EP-A-0 379 147 relates to an extrudable gel as a support for an active principle which can be distributed in a pack equipped with a metering pump. The gel in question contains the active principle in solution and comprises a gelling agent based on an algal extract, for example a carrageenate. The fact that the active principle has to be in solution dictates a low concentration with the result that, in the example provided, the administration of a daily therapeutic dose means that the pump has to be depressed 12 to 60 times on 3 or 4 occasions, consuming the product volume of an entire pack, which is an enormous disadvantage. This drawback cannot be rectified simply by increasing the concentration of the active principle because this would adversely affect the stability of the gel, the mass being viscous and non-gelled and the active principle non-solubilized, and its organoleptic acceptability.